The Effects of Pharmacotherapy on Brain Mechanisms Underlying Cocaine Dependence.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00396734|
Recruitment Status : Suspended (Grant was not renewed)
First Posted : November 7, 2006
Last Update Posted : June 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Opioid-Related Disorders Cocaine-Related Disorders||Drug: Provigil (Modafinil) Drug: Topamax (Topiramate)||Not Applicable|
- To try to elucidate the brain mechanisms underlying cocaine dependence and craving in co-morbid cocaine-dependent patients. For this purpose we shall trigger craving for cocaine by exposure to a videotape showing cocaine use and then measure brain metabolic activity using Positron Emission Tomography (PET) and [18F] Fluorodeoxyglucose (FDG)
- To evaluate dopamine binding in the brain in the early stage, and at the end of treatment. For this purpose the patients will undergo brain imaging of the dopamine receptor DRD2 by using PET with [11C] raclopride. This is a well established procedure for quantifying the effects of drugs such as amphetamine and cocaine on the brain.
- To investigate the association between subjective measures of craving for cocaine and the level of dopamine DRD2 receptor occupancy in the brain.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Modafinil and Topiramate on Brain Mechanisms Underlying Cue-induced Cocaine Craving and Dependence in Methadone Maintained Cocaine Dependent Patients.|
|Study Start Date :||April 2007|
|Estimated Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||April 2011|
Drug: Provigil (Modafinil)
- Changes in cue-induced brain glucose metabolic activity (FDG) in PET after treatment. [ Time Frame: 1 month ]
- Changes in DRD2 receptor density measured by 11 C Raclopride in PET after treatment. [ Time Frame: 1 month ]
- Nr.of drug-free urine samples, time to first drug use, duration of longest abstinent period. [ Time Frame: 1 month ]
- Craving and psychosocial functioning (e.g., employment status, criminal behavior). [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396734
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Study Director:||Aviv M Weinstein, Ph.D||Hadassah Medical Organization|
|Principal Investigator:||Roland Chisin, M.D||Hadassah Medical Organization|